PHILADELPHIA INTERNATIONAL MEDICINE® NEWS BUREAU
Contact: Leonard N. Karp
215/575-3720; lkarp@philadelphiamedicine.com
November 28, 2006
For immediate release:
In this month’s issue:
Editors note: Research, new techniques and improved facilities by Philadelphia International Medicine hospitals and physicians may lead to new ways to treat some of our most challenging diseases. Below are just some examples from our hospitals.
Temple University Hospital Establishes Clinical Hub to Study Neurological Emergencies,
Treatments as Part of NIH Grant
Philadelphia – The National Institutes of Health (NIH) has awarded Temple University Hospital’s Department of Emergency Medicine a $1 million grant to participate as a primary clinical study site in the Neurological Emergencies Treatment Trials (NETT) Network.
The NETT Network initiative is designed to facilitate high-quality clinical trials in multiple types of emergency neurological disorders affecting adults or children. The NETT network will bring together 11 national sites to perform wide-scale clinical trials testing the effectiveness of new treatments for neurological emergencies, which include traumatic brain injuries, seizures, stroke, meningitis, and spinal cord injuries.
Each year, approximately 15 million adults and children visit the emergency department for acute neurological disorders. It is critical to provide optimal care during the first hours of neurological emergencies, which are mostly assessed and treated by emergency physicians.
Temple University Hospital will serve as a clinical hub for this five-year study series; and will establish Phila-NETT, which includes Temple-Episcopal, Temple University Children’s Medical Center, Northeastern Hospital, and Hahnemann Hospital as additional sites. This collaborative, multi-disciplinary effort involves emergency physicians, neurologists, neurosurgeons, interventional radiologists, rehabilitation therapists, and pediatricians.
"Together, we will be a clinical network to recruit, evaluate, and treat patients with neurological emergencies," said Nina Gentile, MD, associate professor, Department of Emergency Medicine, Temple University Hospital, and principal investigator of this project. "We’re very excited about this grant because, in emergency medicine, we often have limited time to decide on the best way to treat patients. These studies will help us further define the right choices."
Dr. Gentile said the goals of the investigation are three-fold: to facilitate high-quality clinical trials in several different types of emergency neurological disorders; to encourage collaboration between emergency medicine physicians and neurological disease specialists in trial design and execution; and to facilitate the implementation of new therapies into clinical practice.
Another key objective of the project is to provide education to a variety of medical professionals, including emergency physicians, neurological specialists, community physicians, and EMTs. "We will collaborate and share resources with other hospitals and medical professionals," said Dr. Gentile. "This is an opportunity to create an infrastructure to work collectively in studies to accurately diagnose and effectively treat neurological disorders."
Personnel at each institution will use sophisticated telemedicine systems for communication and data collection, including user-friendly, web-based technology.
According to Dr. Gentile, Temple was selected as an optimal hub site for these study opportunities for several reasons. "We service such ethnically and racially diverse communities, some of which are often under-represented in clinical studies. Temple also has expertise in neurological emergencies and significant experience in neurological clinical trials."
The NETT network research will begin with a study to determine the safety and effectiveness of intramuscular administration of a medication by paramedics prior to ED arrival; and a study to determine the effects of blood pressure management for intra-cerebral hemorrhage, Dr. Gentile explained. "We will be able to determine interventions to better treat these patients, and will follow their care to assess treatment effectiveness."
CHOP’s Dr. Meadows Pioneer in Field Studying Childhood Cancer Survivors
Children with cancer currently have survival rates approaching 80 percent - a much better rate than adults
diagnosed with the disease today, and a major improvement over survival chances for children diagnosed 20 and 30 years ago. But survivors of childhood cancer may face long-term health problems well into adulthood, as reported today in a large multicenter study of over 10,000 adults who survived a childhood battle with cancer.
One of the co-authors of the Childhood Cancer Survivor Study is a long-standing pioneer in the field. Anna T. Meadows, MD, and colleagues at The Children's Hospital of Philadelphia were the first researchers to investigate the late effects of childhood cancer, starting in the mid-1970s. An oncologist, Dr. Meadows is the medical director of the Cancer Survivorship Program at Children's Hospital.
Dr. Meadows serves on the steering committee of the Childhood Cancer Survivor Study (CCSS), which published the research, the largest-ever study of adult survivors of childhood cancer in the Oct. 12 issue of the New England Journal of Medicine. Sponsored by the National Cancer Institute, the collaborative study drew on researchers from more than two-dozen cancer centers throughout the U.S. and Canada.
In comparing more than 10,000 adult survivors of pediatric cancer to approximately 3,000 of their siblings, the researchers found survivors to be more than three times as likely to have a chronic health condition, and
more than eight times as likely to have a severe or life-threatening condition. The incidence of these chronic conditions increased over time and did not appear to level off over the time span that was studied.
The long-term survivors, first diagnosed with cancer between 1970 and 1986, were particularly vulnerable to second cancers, heart conditions, kidney disease, severe musculoskeletal problems and endocrine abnormalities such as thyroid disease, osteoporosis and sterility. Female survivors were at higher risk than male survivors for chronic illnesses.
One implication of the current study, said Dr. Meadows, is the need for continued medical surveillance of adult survivors of childhood cancer. "Fewer than 20 percent of these patients are followed by an oncologist or at a cancer center, but they clearly have special medical needs and higher risks," she added. There are currently 270,000 survivors of pediatric cancer in the U.S.
Dr. Meadows is nationally recognized as an expert in treatment-related effects of children's cancer. Her studies in the 1970s and 1980s showed that brain radiation used to treat children with leukemia damaged the children's cognitive development and raised their risk of later brain cancer. That research helped to change medical practice, as physicians eliminated or reduced radiation doses to the head during treatment for childhood leukemia.
Because of such studies on treatment effects, and based on many clinical trials in pediatric oncology that have led to improved treatments over the years, Dr. Meadows predicts that children diagnosed with cancer since 1987 will have fewer chronic problems as survivors than the cohort analyzed in the current study.
On the strength of her clinical and research experience with childhood cancer survivors, Dr. Meadows became the first director of the Office of Cancer Survivorship at the National Cancer Institute, serving from 1996 to 1999. She has been part of the CCSS since its inception in 1993, and chairs its publication committee, guiding the organization's output of some 50 articles.
As the home of one of the nation's largest pediatric cancer programs, The Children's Hospital of Philadelphia was among the largest sources of former patients in the current study. The hospital's Cancer Survivorship Program, directed by Dr. Meadows, brings together specialists from oncology, cardiology, endocrinology, pulmonology, nutrition and psychology to meet the special needs of survivors.
The study was supported by a Department of Health and Human Services grant to the senior author, Leslie L. Robison, PhD, of St. Jude Children's Research Hospital, Memphis, TN. The corresponding author of the study is Kevin C. Oeffinger, MD, of Memorial Sloan-Kettering Cancer Center, New York City.
Jefferson Oncologists Show Less Radiation Just as Effective in Fighting Brain Tumor, Saving Hearing
Radiation oncologists at the Kimmel Cancer Center at Thomas Jefferson University and Thomas Jefferson University Hospital in Philadelphia have found that giving less radiation than usual is just as effective against a benign but potentially devastating brain tumor called an acoustic schwannoma, and better yet, might save more of the patient’s hearing.
Only about 2,000 to 3,000 cases of acoustic schwannomas occur annually in the United States. Because it’s a slow-growing tumor that develops in the vestibular nerve that lies very close to the auditory, or hearing, nerve, the most common symptom is hearing loss. Left untreated, the hearing loss can be severe. While surgery is the only way to remove the tumor, it’s tricky and can potentially damage surrounding cranial nerves. Treating the tumor with radiation is usually effective, less risky, and the vast majority of tumors do not grow back, says Maria Werner-Wasik, MD, associate professor of radiation oncology at Jefferson Medical College of Thomas Jefferson University.
But higher doses of radiation carry some risks of hearing damage too. Dr. Werner-Wasik, David Andrews, MD, professor of neurological surgery at Jefferson Medical College, and their co-workers wanted to find out if lower doses would work just as well. They compared two groups among 115 patients with acoustic schwannomas treated at Thomas Jefferson University Hospital between 1994 and 2005. One group of 74 patients received fractionated doses – small, daily doses of radiation – resulting in "excellent tumor control and reasonable hearing preservation," she says. The remaining 41 patients also received fractionated doses, but at a lower radiation dose.
The researchers found that the local tumor control was the same for both groups, around 98 to 100 percent. The fifth and seventh nerve toxicity was the same – between 0 and 2 percent, but the hearing seemed slightly better in the lower dose group than in the higher dose. They report their results on November 7, 2006 at the annual meeting of the American Society for Therapeutic Radiology and Oncology in Philadelphia.
When the researchers adjusted statistically for patients in both groups that had only up to three years of follow-up, they found a significant improvement in hearing as gauged by "pure tone average," or PTA, which is the loudness in decibels that an individual patient can hear. Patients who had the higher radiation dose had a mean difference in PTA before and after treatment of 15.4, versus those in the lower dose level, at 5.7.
"We think that the lower dose level is associated with equally good local control and better hearing preservation, and we’ll continue to make these observations and perhaps further reduce the doses," says Dr. Werner-Wasik. Lower radiation doses mean shorter treatment times and fewer visits. Patients received the lower dose over 26 treatments, while those who received the higher dose required 30 treatments. She notes that similar results were found by other researchers using Gamma Knife technology.
"While the standard of care has been surgery for most patients, the pendulum is swinging to radiation becoming the new standard for most as an initial treatment," she says.
Fox Chase: Largest Study to Evaluate PSA "Bounce" Shows Overall Survival Is Not Affected
A study involving more than 7,500 men with prostate cancer treated with radiation concludes that a rise in the PSA level after treatment—called PSA bounce—does not have clinical relevance and does not affect survival. The results of this multi-institutional study were presented at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology in Philadelphia.
"Radiation oncologists and urologists have been observing the PSA bounce for several years without knowing for sure if it had any clinical significance," explained Eric Horwitz, MD, clinical director of the Radiation Oncology Department at Fox Chase Cancer Center and author of the study. Now we have a large body of evidence showing it doesn’t."
PSA, or prostate specific antigen, is measured by a blood test and used to determine if prostate cancer is present.
One key endpoint of the study was to determine if there was a survival difference between the patients who experienced a PSA bounce and those who did not. The data evaluated were from two multi-institutional pooled datasets—4,839 patients (9 institutions) with early prostate cancer treated with external-beam radiation alone and 2,693 patients (11 institutions) treated with seed implants. The datasets for these men spanned an average of 10 years.
Of those who experienced a PSA bounce, 902 patients were treated with external-beam therapy and 470 patients were treated with seed implants, also known as brachytherapy. A PSA bounce was defined as an increase of at least 0.2 ng/ml over a previous PSA measurement followed by a decline.
"A significant number of men experienced at least one PSA bounce after treatment, usually within one to three years after treatment," said Dr. Horwitz. "However, after 10 years, there were no statistical differences in overall survival of patients who had a bounce and those who did not."
Dr. Horwitz said the study also showed no difference between the two groups regarding other clinically important endpoints, including biochemical failure (PSA level after treatment), distant metastasis-free survival and cause-specific survival. Biochemical failure was determined by the newest method—Nadir +2.
Fox Chase Cancer Center was founded in 1904 in Philadelphia as the nation’s first cancer hospital. In 1974, Fox Chase became one of the first institutions designated as a National Cancer Institute Comprehensive Cancer Center. Fox Chase conducts basic, clinical, population and translational research; programs of prevention, detection and treatment of cancer; and community outreach.
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